Foundation Medical Partners understands the critical need for cutting-edge diagnostic tools in the fight against advanced cancer. Two key innovations in this space are FoundationOne®CDx and FoundationOne®Liquid CDx. These next-generation sequencing based in vitro diagnostic tests are designed for patients with advanced solid tumors and are available by prescription only. They represent significant advancements in personalized cancer care, offering the potential to tailor treatments based on a patient’s unique genomic profile.
FoundationOne CDx utilizes FFPE tissue samples to analyze 324 genes and crucial genomic signatures. This comprehensive approach provides a detailed understanding of the tumor’s genetic makeup. Similarly, FoundationOne Liquid CDx analyzes circulating cell-free DNA, examining 324 genes and holding FDA approval for reporting short variants in 311 genes. A significant application of these tests lies in their role as companion diagnostics. They are instrumental in identifying patients who may be suitable candidates for specific targeted therapies, aligning with the approved therapeutic product labeling. This targeted approach is crucial for effective treatment strategies in advanced cancer.
It’s important to note that while these tests offer valuable genomic insights, they do not guarantee treatment matching, and a negative result does not exclude the presence of alterations. In some cases, a biopsy may be necessary for FoundationOne CDx testing if archival tissue isn’t available, which carries potential risks. For therapies like ROZLYTREK® (targeting NTRK1/2/3 and ROS1 fusions) or TEPMETKO® (targeting MET exon 14 skipping), plasma specimens are only appropriate for FoundationOne Liquid CDx testing when tumor tissue is unavailable.
Patients tested with FoundationOne Liquid CDx who are negative for other companion diagnostic mutations should undergo reflex testing with tumor tissue and have mutation status confirmed using an FDA-approved tissue test, if possible. These protocols ensure the most accurate and reliable diagnostic information is used to guide treatment decisions.
For complete details, including companion diagnostic indications and important risk information, refer to the full labels available at www.F1CDxLabel.com and www.F1LCDxLabel.com. Foundation Medical Partners recognizes the value of these advanced diagnostic tools in empowering healthcare professionals and improving outcomes for patients facing advanced cancer.
